MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB724
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Additional information was requested, and the following was obtained: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify=>removal from package h3 investigation summary: the product was returned to ethicon for evaluation.One winding forming with eight detached needles, and two sutures were received for analysis.The product code jb724 is control release and requires eight strands single armed per packet.Upon visual inspection of the detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The dispensed sutures were inspected, and the insertion end did not meet the requirement.In addition, the other five sutures were not returned for evaluation.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.H6 component code: g07002 no problem found the product was returned to ethicon for evaluation.One open box with five unopened samples were received for analysis.Product code jb724.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force results met with the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date.During the procedure, the needle had been detached from the suture when the needle was grasped with a needle holder and the suture was pulled out.It was a control release needle.There were no adverse consequences to the patient.Additional information was requested.Upon evaluation of the returned device, the insertion end did not meet the requirement.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CTXB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21286918
• Report Number: 2210968-2025-01161
• Device Sequence Number: 20810581
• Product Code: GAM
• UDI-Device Identifier: 10705031043954
• UDI-Public: (01)10705031043954(17)280531(10)TGMCMH
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: JB724
• Device Lot Number: TGMCMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown